CAPA Engineer II
- Career development with an international company where you can grow the career you dream of.
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- An excellent retirement savings plan with a high employer contribution
- Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
- A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
- Communicate confidently and effectively with all levels of management, peers and key stakeholders, including timely escalation of quality issues.
- Participate in, or lead, the completion of CAPA projects, assuring compliance, quality and timeliness of records.
- Collaborate with cross-functional teams using various methodologies (e.g. Six Sigma root cause analysis/problem solving skills).
- Independently investigate, gathers data, and perform preliminary analysis.
- Process requests, ensuring owners are assigned, and timely responses and approvals are provided in alignment with quality goals.
- Lead meetings and communications for CAPA updates, information, and concerns.
- Responsible for assisting with metrics and reporting on regular basis in accordance with established procedures.
- Support team in the delivery and oversight of CAPA training program.
- Assist in the initiation, processing and completion of CAPA records in the electronic system.
- Execute and provide on-time completion of Quality Assurance engineering deliverables.
- Provide support and subject matter expertise during audits and inspections.
- Lead and/or contribute to continuous improvement initiatives and projects.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
- Bachelor's Degree in Engineering, Healthcare or Life Science or an equivalent combination of education and work experience.
- 2 years of engineering and/or technical operational experience plus demonstrated competence.
- Previous CAPA and/or quality assurance/engineering experience and demonstrated use of quality tools/methodologies.
- Prior medical device experience preferred.
- Detailed knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO 13485 : 2016.
- Solid communication and interpersonal skills.
- Demonstrated and impactful project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
- Advanced computer skills, including statistical/data analysis and report writing skills.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Ability to leverage and/or engage others to accomplish projects.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Multitasks, prioritizes and meets deadlines in timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
- Ability to travel approximately 10%, including internationally.
- Ability to maintain regular and predictable attendance.
- Master's Degree in related field preferred.
- Six Sigma root cause analysis/problem solving training and experience preferred.
- Experience working in a broader enterprise/cross-division business unit model preferred.
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